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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Rachael
Heys
+44 (0)117 455 3012
zosterflucov-trial@bristol.ac.uk
Dr
Rajeka
Lazarus
+44 (0)117 3429266
Rajeka.Lazarus@uhbw.nhs.uk
Dr
Rachael
Heys
+44 (0)117 455 3012
zosterflucov-trial@bristol.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Shingles, influenza, COVID-19 (SARS-CoV-2 infection)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Shingles is a common and painful disease, it can result in long-term pain and in rare cases can even be fatal. It is recommended that all adults in the UK are offered the shingles vaccine on their 70th birthday. Uptake of the shingles vaccine is suboptimal, therefore strategies to improve uptake are needed.
Routine reporting of the shingles vaccine suggests that uptake is greater during the influenza season, and it is assumed this is due to it being offered at the same time as the annual flu vaccine. A new vaccine for shingles has been recommended since 2021, a recombinant herpes zoster vaccination.
Up until May 2023 concomitant administration of RZV with either adjuvanted or COVID-19 vaccine (C19) was not recommended due to concern about misattribution of side-effects and limited experience with COVID-19 vaccines. The policy was updated in May 2023 to allow co-administration of COVID-19 vaccines with any vaccine. This was based on recent evidence supporting the acceptable safety profile of a COVID-19 vaccine with RZV and to improve timely protection and uptake. There is still a need however for safety data with co-administration of second dose of RZV as the adverse event profile differs between the doses and there is a lack of published data on the safety and immunogenicity of RZV and adjuvanted flu vaccine.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 23/11/2023:
1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol
2. Written informed consent obtained from the participant prior to any study-specific procedure
3. Adults aged 50 years and over at the time of randomisation
4. Participants must have documented history (e.g. NHS app, GP record) or receiving their initial course (usually two doses) of any type of COVID-19 vaccinaiton, irrespective of the type of COVID-19 vaccine received.
5. Female participants of childbearing potential must be willing to ensure that they or their partner use effective contraception from 1 month prior to first vaccination continuously until 3 months after final vaccination*
*A woman of childbearing potential is defined as a pre-menopausal female who is capable of becom
You may not be able to take part if:
Current participant exclusion criteria as of 22/10/2024:1. Any clinical condition that in the opinion of the investigator might pose additional risk to the participant due to participation in the study.2. History of reaction or hypersensitivity likely to be exacerbated by any component of the study intervention including allergic reaction to any component of any of the studyvaccines, known reactions related to study vaccines e.g. history of myocarditis, GuillainBarre Syndrome.3. Unstable medical condition on the day of enrolment as determined by clinical history and examination.4. Bleeding disorders or continuous use of anticoagulation medicine, such as coumarins and related anticoagulants (i.e., warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban). Use of aspirin is allowed.5. Any confirmed or suspected immunosuppressive, or immunodeficient condition, based on medical history and physical examination. People living with HIV that is well controlled can be included in the study.* Those with a new diagnosis or an AIDs defining illness in the past 12 months cannot be included.6. Use of immunosuppressive medication, ongoing, long term or planned, defined as more than 14 days in total of immunosuppressant treatments. For corticosteroids this will meanmore than 14 days of prednisolone >20mg/day or equivalent. Use of inhaled, intraarticular and topical steroids is allowed.7. Use or planned use of long-acting immune modifying drugs in the 12-month period before randomisation (e.g. infliximab).8. COVID-19 or influenza vaccination 90 days prior to the study vaccination9. Previous vaccination with a live herpes zoster vaccine within the past 5 years.10. Administration of monoclonal antibodies (including those targeting SARS CoV2), immunoglobulins and/or blood products during the 3 months before the first dose of the study vaccines, up to 1 month after the last dose or planned during the study period.11. Planning to or concurrently participate in another interventional clinical study.12. Pregnancy, lactation or willingness/intention to become pregnant within the study period.13. Previous participation in the ZosterFluCOV trial.*Defined as less than 50 copies/ml (convert as needed from IU/ml) on the last two occasions >3 months apart, and a CD4 over 500 when last checked.
Previous participant exclusion criteria as of 23/11/2023: 1. Any clinical condition that in the opinion of the investigator might pose additional risk to the participant due to participation in the study2. History of reaction or hypersensitivity likely to be exacerbated by any component of the study intervention including allergic reaction to any component of any of the study vaccines, known reactions related to study vaccines e.g. history of myocarditis, Guillain-Barre Syndrome3. Unstable medical condition on the day of enrolment as determined by clinical history and examination4. Bleeding disorders5. Any confirmed or suspected immunosuppressive, or immunodeficient condition, based on medical history and physical examination. People living with HIV that is well controlled can be included in the study.* Those with a new diagnosis or an AIDs defining illness in the past 12 months cannot be included. 6. Use of immunosuppressive medication, ongoing, long term or planned, defined as more than 14 days in total of immunosuppressant treatments. For corticosteroids this will mean more than 14 days of prednisolone >20 mg/day or equivalent. Use of inhaled, intra-articular and topical steroids is allowed.7. Use or planned use of long-acting immune modifying drugs in the 12-month period before randomisation (e.g. infliximab)8. COVID-19 or influenza vaccination 90 days prior to study vaccination 9. Previous vaccination with a live herpes zoster vaccine within the past 5 years10. Administration of monoclonal antibodies (including those targeting SARS-CoV-2), immunoglobulins and/or blood products during the 3 months before the first dose of the study vaccines, up to 1 month after the last dose or planned during the study period11. Planning to or concurrently participating in another interventional clinical study12. Pregnancy, lactation or willingness/intention to become pregnant within the study period13. COVID-19 or flu vaccine within 90 days, any other vaccine within 30 days of study vaccination*Defined as less than 50 copies/ml (convert as needed from IU/ml) on the last two occasions >3 months apart, and a CD4 over 500 when last checked.
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Previous participant exclusion criteria:1. Any clinical condition that in the opinion of the investigator might pose additional risk to the participant due to participation in the study2. History of reaction or hypersensitivity likely to be exacerbated by any component of the study intervention including allergic reaction to any component of any of the study vaccines, known reactions related to study vaccines e.g. history of myocarditis, Guillain-Barre Syndrome3. Unstable medical condition on the day of enrolment as determined by clinical history and examination4. Bleeding disorders5. Any confirmed or suspected immunosuppressive, or immunodeficient condition, based on medical history and physical examination6. Use of immunosuppressive medication, ongoing, long term or planned, defined as more than 14 days in total of immunosuppressant treatments. For corticosteroids this will mean more than 14 days of prednisolone >20 mg/day or equivalent. Use of inhaled, intra-articular and topical steroids is allowed. 7. Use or planned use of long-acting immune modifying drugs in the 12-month period before randomisation (e.g. infliximab)8. Planned vaccination within 30 days of study vaccination9. Previous vaccination with a live herpes zoster vaccine within the past 5 years10. Administration of monoclonal antibodies (including those targeting SARS-CoV-2), immunoglobulins and/or blood products during the 3 months before the first dose of the study vaccines, up to 1 month after the last dose or planned during the study period11. Planning to or concurrently participating in another interventional clinical study12. Pregnancy, lactation or willingness/intention to become pregnant within the study period13. COVID-19 or flu vaccine within 90 days, any other vaccine within 30 days of study vaccination
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Rachael
Heys
+44 (0)117 455 3012
zosterflucov-trial@bristol.ac.uk
Ms
Rachael
Heys
+44 (0)117 455 3012
zosterflucov-trial@bristol.ac.uk
Dr
Rajeka
Lazarus
+44 (0)117 3429266
Rajeka.Lazarus@uhbw.nhs.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University Hospitals Bristol NHS Foundation Trust and funded by GlaxoSmithKline.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 54747
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
